John Krayer

Nonclinical Safety Lead (Expert Representative) on Cross Functional Project Teams supporting development strategies for small and large molecule (bio)therapeutics. Interacted with team members to facilitate progression of compounds through early and late phase development, compilation of Pharmacology/ Toxicology sections of regulatory filings, and responsed to regulatory inquiries. Managed a team of Study Toxicologists that supported Nonclinical Safety in the execution of strategy. Study monitor responsibilities included interfacing with Toxicology Contract Research Organizations (CRO’s) in the design of toxicology study protocols, conduct of studies, data interpretation, and preparation of final reports. CRO study monitoring performed as needed. Due diligence reviews of licensing opportunities. Performed numerous health hazard assessments.

Biologics Toxicology Expert Representative on Compound Development Project Teams (CDT’s). Interact with members of CDT and Biologics Toxicology to facilitate progression of compounds through early and late phase development, compilation of the Pharmacology/ Toxicology sections of regulatory filings, and response to regulatory inquiries. Study monitor responsibilities include interfacing with Toxicology Contract Research Organizations (CRO’s) in the design of toxicology study protocols, conduct of studies, data interpretation, and preparation of final reports. CRO study monitoring performed as needed. Due diligence review of licensing opportunities. Contact within Biologics Toxicology for the conduct and reporting of health hazard assessments.

Biologics Toxicology Expert Representative on Compound Development Project Teams (CDT’s). Interact with members of CDT’s and Biologics Toxicology to facilitate progression of compounds through early and late development, compile the Pharmacology/Toxicology sections of regulatory filings. Study monitor responsibilities include interfacing with Toxicology Contract Research Organizations (CRO’s) in the design of toxicology study protocols, conduct of studies, data interpretation, and preparation of final reports. CRO study monitoring performed as needed. Contact within Biologics Toxicology for the conduct and reporting of health hazard assessments.

Study Director/Monitor for in-house and contracted Safety Assessment (SA) reproductive and general toxicology studies for a variety of development compounds. Responsibilities include planning, coordination and oversight of studies; protocol and report preparation and review; interaction with Project Representatives to coordinate activities. SA Project Representative on a matrix project team for oncology candidate compounds that includes coordination of SA activities, interaction with members of core and program/project team to coordinate SA activities, and representation of SA at team meetings.

Lead Toxicologist on multi-disciplined Preclinical Development technical teams for several development compounds; Responsibilities included planning, coordination and oversight of general and reproductive toxicity studies; protocol and report review; preparation and review of submission documents; study monitor for contracted studies; Due diligence review of licensing opportunities; critical review of competitors in-class compounds either on the market or in development. Study Director for Drug Evaluation (early lead) safety assessment studies.

Study Director responsibilities in reproductive toxicology laboratory including supervision of associate staff while performing studies; Assisted with preparation and review of relevant sections in submission documents; Drug Evaluation team representative for reproductive toxicology discipline; Review of CRO reports; Proposed and instituted new process for expedited study reporting.

Preparation, conduct and reporting of reproductive toxicology studies including Study Director responsibilities.

Protocol preparation, animal dosing, necropsies, fetal evaluations and draft reporting of reproductive toxicology studies.

Dosing, necropsies, and fetal evaluations for reproductive toxicology studies.

Research activities in neuroanatomy